Cairn Surgical Finalizes Enrollment for European Novel Breast Cancer System

Cairn Surgical has completed patient enrollment in its European post-market clinical study of the Breast Cancer Locator (BCLTM) System. The BCL System is designed to improve the accuracy of breast conserving surgery (lumpectomy) by providing precise guidance regarding tumor shape, size, and location, thus enabling the ability to achieve clear margins.
 
“In this study, the Breast Cancer Locator exceeded our expectations in enabling us to achieve negative margins, which is what we strive for in every case,” said Prof. Dr. Marc Thill, Chief of Gynecology and Gynecologic Cancer at Agaplesion Markus Krankenhaus, Frankfurt, Germany, and clinical investigator in the study. “It is clear that having detailed guidance regarding the size, shape, and location of each tumor in the supine position enables us to improve our surgical outcomes.”
 
The multicenter European post-market surveillance clinical study encompassed 33 patients who underwent breast-conserving surgery to remove a breast tumor using the BCL System, per protocol. Clinical data from the study is expected to be presented in a clinical forum later this year.
 
Patients were treated at five centers, including Santa Chiara Hospital in Pisa, Italy; Spital Zollikerberg in Zollikerberg, Switzerland; Humanitas Research Hospital in Rozanno, Italy; Klinik Sankt Elizabeth in Heidelberg, Germany; and Agaplesion Markus Krankenhaus in Frankfurt, Germany. The primary endpoint is the positive margin rate, which is assessed by imaging and pathology immediately following the procedure. 
 
“The combination of the patient-specific Breast Cancer Locator and the real-time VisualizerTM was intuitive to use and provided us with interactive multi-angle views of the tumor,” said Prof. Dr. Michael Golatta, Brustzentrum Heidelberg, Klinik Sankt Elisabeth, Heidelberg, Germany, clinical investigator in the study
 
The BCL System is designed to reduce positive margin rates and to improve the workflow of breast-conserving surgery. A supine MRI with the breast positioned in its surgical position for the greatest accuracy is first performed, with a customized 3D-printed form. 
 
The BCL is designed and produced from the image to fit the unique shape of that patient’s breast. During surgery, the BCL and the Visualizer an interactive, real-time, 3D images of the tumor in the breast, which are used by the surgeon to provide valuable references during tumor excision. 
 
The U.S. pivotal trial of 448 women treated with the Breast Cancer Locator (BCL) System at up to 25 centers is currently enrolling patients and is designed to support FDA clearance and U.S. commercialization. The primary endpoint is positive margin rate, with other endpoints including specimen volumes, rate of additional shave biopsies, re-excision rate, cancer localization rate, operative time, and cost of care. 
 
In earlier clinical studies of the BCL System, published in the Annals of Surgical Oncology¹ and in Surgical Oncology², clear tumor margins were achieved in all patients.

References:

^1. Barth RJ, Krishnaswamy V, Paulsen KD, et al. A patient-specific 3D-printed form accurately transfers supine MRI-derived tumor localization information to guide breast-conserving surgery. Ann Surg Oncol. 2017; 24(10): 2950-2956.
^2. Barth RJ, Krishnaswamy V, Rooney T, et al A pilot multi-institutional study to evaluate the accuracy of a supine MRI based guidance system, the Breast Cancer Locator™, in patients with palpable breast cancer. Surgical Oncology, Vol 44, September 2022, 101843.